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Subjective Cognitive Decline (SCD)PENSA+NCT07730671

PENSA+: Extended Follow-up of a Multimodal Lifestyle Intervention to Prevent Cognitive Decline in APOE-ε4 Carriers

An observational study of Subjective Cognitive Decline (SCD), run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

PENSA+ is a 5-year follow-up study of participants who previously completed the PENSA clinical trial (NCT03978052), which evaluated an intensive multimodal lifestyle intervention, with or without epigallocatechin gallate (EGCG), in APOE-ε4 carriers with subjective cognitive decline, a population at increased risk of… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Subjective Cognitive Decline (SCD)
How many people
121 participants
Where
1 siteSpain
Study dates
1 Sep 2026to Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals who previously completed the PENSA study will constitute the target population of this study. Of the 129 participants initially enrolled in the PENSA study, 121 completed it. Participants who completed the PENSA study were allocated as follows: * 47 participants in the MLI+EGCG group * 49 participants in the MLI+placebo group * 25 participants in the CG

Who may be able to join

  • Any individual who has completed the PENSA study, does not meet any exclusion criteria, and provides consent is eligible to participate in this study.

Who cannot join

  • Participants will be excluded from the study if they meet any of the following conditions:
  • A prior clinical diagnosis of dementia, regardless of etiology.
  • Current institutionalization (e.g., residence in nursing homes, long-term care facilities, or similar institutions).
  • Impaired decision-making capacity, defined as the inability to provide informed consent independently due to cognitive, legal, or medical reasons (e.g., loss of autonomy or requirement of a legal representative).
  • Current participation in another interventional clinical trial, or participation in an interventional clinical trial within the previous 3 months prior to baseline; unless deemed by the investigator not to interfere with PENSA+ procedures or outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natàlia Soldevila Domènech, MPH, PhD contact

(+34) 93 316 09 90

nsoldevila@barcelonabeta.org

Spain1 site

  • Fundació Pasqual Maragall

    Barcelona, Catalonia, 08005

    Anna Soteras Prat, +34 933 26 31 90, asoteras@barcelonabeta.org

    Natàlia Soldevila Domènech, MPH, PhD

Other trials in Spain

About this study

Official title: Evaluation of the Long-Term Cognitive, Biological, and Lifestyle Effects of a Multimodal Intervention for Preventing Cognitive Decline in APOE-ε4 Carriers With Subjective Cognitive Decline

PENSA+ is a 5-year follow-up study of participants who previously completed the PENSA clinical trial (NCT03978052), which evaluated an intensive multimodal lifestyle intervention, with or without epigallocatechin gallate (EGCG), in APOE-ε4 carriers with subjective cognitive decline, a population at increased risk of developing Alzheimer's disease.

The purpose of this study is to determine whether the cognitive, biological, and lifestyle benefits observed after the original intervention are maintained over the long term. Researchers will evaluate cognitive performance, the incidence of mild cognitive impairment, dementia risk, brain imaging, blood biomarkers, physical fitness, lifestyle behaviors, and psychosocial factors approximately five years after completion of the intervention.

The study will also investigate the biological and behavioral mechanisms associated with sustained cognitive benefit, identify participant characteristics associated with better long-term outcomes, evaluate the long-term cost-effectiveness of the intervention using healthcare utilization data, and explore whether lifestyle changes have influenced participants' study partners. No new intervention will be administered as part of this follow-up study.

Read the detailed description

Alzheimer's disease (AD) is the leading cause of dementia and is characterized by a long preclinical phase during which pathological changes accumulate before the onset of clinical symptoms. This extended asymptomatic period provides an opportunity to implement preventive strategies aimed at delaying or reducing cognitive decline. Multidomain lifestyle interventions targeting modifiable risk factors have emerged as one of the most promising approaches for dementia prevention, demonstrating beneficial effects on cognitive performance and overall brain health, particularly in individuals at increased risk of developing AD. However, the long-term durability of these effects, the biological mechanisms underlying sustained benefit, the characteristics of individuals most likely to respond, and the long-term economic value of these interventions remain incompletely understood.

The PENSA+ study is a long-term follow-up of the PENSA randomized clinical trial (NCT03978052), which evaluated an intensive personalized multimodal lifestyle intervention in cognitively unimpaired APOE-ε4 carriers with subjective cognitive decline. The intervention combined dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management, and was administered with either epigallocatechin gallate (EGCG)-a naturally occurring green tea polyphenol with antioxidant, anti-inflammatory, metabolic, vascular, and potential neuroprotective properties-or placebo. Participants assigned to the control group received general healthy lifestyle recommendations. The original trial demonstrated improvements in cognitive performance, lifestyle behaviors, physical fitness, cardiometabolic health, and dementia risk in the intervention groups, with cognitive and lifestyle benefits persisting beyond the active intervention period. However, whether these benefits are maintained over the longer term and the mechanisms responsible for their persistence remain unknown.

The primary objective of PENSA+ is to evaluate cognitive performance, the incidence of mild cognitive impairment, and dementia risk approximately five years after completion of the original intervention. Secondary objectives are to investigate the biological, behavioral, and psychosocial mechanisms associated with sustained cognitive benefit, identify long-term responder phenotypes, and evaluate the long-term cost-effectiveness and cost-utility of the intervention. Exploratory objectives include assessing long-term clinical outcomes and healthcare resource utilization through electronic health records for up to 10 years after the intervention and evaluating potential spillover effects on participants' study partners.

Participants who completed the original PENSA trial will undergo comprehensive follow-up evaluations, including cognitive, neurological, neuroimaging, biomarker, physical fitness, lifestyle, and psychosocial assessments. Data collected during the original trial will be integrated with the five-year follow-up data to characterize long-term cognitive trajectories, identify determinants of sustained cognitive resilience, and provide evidence on the long-term clinical and economic impact of intensive multidomain lifestyle interventions for Alzheimer's disease prevention.

Keywords
Alzheimer's Disease, Dementia Prevention, Subjective Cognitive Decline, APOE-ε4 carriers, Multidomain Lifestyle Intervention, Epigallocatechin Gallate (EGCG), Brain Health, Blood Biomarkers, Long-Term Follow-up, Subjective Cognitive Decline (SCD)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07730671
Study groupRoleWhat they receive
Multimodal Lifestyle Intervention + EGCGParticipants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with epigallocatechin gallate (EGCG) supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.
Multimodal Lifestyle Intervention + PlaceboParticipants who completed the original PENSA trial and were assigned to the intensive personalized multimodal lifestyle intervention combined with placebo supplementation for 12 months. The intervention included dietary counseling, physical exercise, cognitive training, psychoeducation, social stimulation, and vascular risk management. Participants are followed approximately 5 years after completion of the intervention (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.
ControlParticipants who completed the original PENSA trial and were assigned to the control group, receiving general healthy lifestyle recommendations without the intensive multimodal intervention. Participants are followed approximately 5 years after completion of the original study (current PENSA+ study) to evaluate long-term cognitive, biological, lifestyle, and health outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Cognitive Performance (PACC-exe Composite Score)

    Global cognitive performance assessed using the Preclinical Alzheimer Cognitive Composite for executive function, a composite score derived from six neuropsychological tests: Montreal Cognitive Assessment (score 0-30, higher scores indicate better cognition), Free and Cued Selective Reminding Test (score 0-48, higher scores indicate better episodic memory), Logical Memory Delayed Recall from the Wechsler Memory Scale (score 0-48, higher scores indicate better delayed verbal memory), WAIS-IV Coding (higher scores indicate better processing speed), Stroop Color-Word Test Interference score (higher scores indicate better inhibitory control and executive function), and Five Digit Test (higher scores indicate better executive functioning and cognitive flexibility). Individual test scores are converted to standardized z-scores based on the baseline mean and standard deviation of the study cohort, and the PACC-exe score is calculated as the arithmetic mean of these z-scores.

    Measured: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention

  2. Incidence of Mild Cognitive Impairment (MCI)

    Incidence of Mild Cognitive Impairment determined according to clinical diagnostic criteria based on neuropsychological evaluation and clinical assessment performed at the 5-year follow-up visit.

    Diagnosis will require: (1) evidence of objective cognitive impairment on standardized neuropsychological assessment; (2) reported cognitive decline from previous functioning by the participant, an informant, or documented longitudinal assessment; (3) preserved independence in activities of daily living (impaired performance will be defined as below the 10th percentile, scaled score <7, or ≥1.3 SD below age- and education-adjusted normative means); and (4) absence of dementia. Domain-specific impairment will be defined as low performance in ≥3 of 5 memory measures, ≥3 of 5 executive function measures, or ≥2 of 2 language measures. Final diagnosis will be established by a neurologist based on the integrated evaluation of neuropsychological, clinical, functional, and behavioral information.

    Measured: Approximately 5 years after completion of the original PENSA intervention

  3. Dementia Risk (LIBRA Index)

    Dementia risk assessed using the Lifestyle for Brain Health (LIBRA) Index, a weighted composite score of modifiable risk and protective factors for dementia. Lower scores indicate lower estimated dementia risk.

    The dementia risk assessed with the LIBRA Index is a weighted composite score of 12 modifiable risk and protective factors for dementia. These modifiable risks are the following:

    1. Coronary heart disease
    2. Chronic kidney disease
    3. Hypertension
    4. Hypercholesterolemia
    5. Diabetes
    6. Depression
    7. High cognitive activity
    8. Obesity
    9. Low/moderate alcohol use
    10. Physical inactivity
    11. Smoking
    12. Healthy diet

    Measured: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention

Secondary outcomes (8)

  1. Longitudinal changes in memory and executive function

    Longitudinal changes in cognitive domains (memory and executive function scores, PMCID: PMC12413734).

    Measured: Baseline, 12-month, 5-year

  2. Longitudinal changes in Mediterranean diet adherence

    Diet will be assessed through Mediterranean Diet Adherence Screener (MEDAS-14). The MEDAS-14 is a 14-item questionnaire for the assessment of Mediterranean diet compliance. It has been developed and validated by researchers of the PREDIMED study (PMCID: PMC8710807). The maximum possible score is 14 points.

    This questionnaire allows the participants to be classified according to their adherence to the Mediterranean diet, being appropriate if the score is ≥10 or not appropriate if the score is <10.

    Measured: Baseline, 12-month, 5-year

  3. Longitudinal changes in physical activity

    Physical activity is measure through the Short Minnesota Leisure Time Activities Questionnaire (VREM). The VREM questionnaire asks for information on six activities carried out in the last month (or usual month) in order to find out the level of PA performed: walking, gardening in the garden, doing sport or dancing, climbing stairs, shopping on foot, and cleaning the house. cleaning the house (PMID: 23223762). According to the number of minutes spent on each activity and the frequency they are carried out over the course of a year, the energy expenditure is estimated for 14 days, expressed in Metabolic Equivalents (METs) per minute per 14 days (MET-min-14 days). The VREM makes it possible to distinguish between very active (more than 5,000 MET-min-14 days), active (between 3,000 and 4,999), moderately active (between 1,250 and 2,999), and sedentary (less than 1,250).

    Measured: Baseline, 12-month, 5-year

  4. Longitudinal changes in quality of life

    Quality of life is measured through the World Health Organization Quality of Life (WHOQOL)-BREF. The WHOQOL-BREF comprises 26 items, categorized into four domains: physical health (7 items), psychological well-being (6 items), social connections (3 items), and environmental health (8 items) (PMID: 15085902). Additionally, it includes items addressing the overall quality of life and general health. Each item in the WHOQOL-BREF is assessed on a five-point ordinal scale. These scores are then linearly transformed to a 0-100 scale. The physical health domain encompasses aspects such as mobility, daily activities, functional capacity, energy, pain, and sleep. Within the psychological domain, assessments cover self-image, negative thoughts, positive attitudes, self-esteem, mentality, learning ability, memory concentration, religion, and mental status. The social relationships domain explores personal relationships, social support, and aspects of one's sex life.

    Measured: Baseline, 12-month, 5-year

  5. Longitudinal changes in physical fitness - Senior Fitness Test

    Physical fitness will be assessed using the Senior Fitness Test (SFT), a standardized battery that evaluates overall physical fitness in older adults, including muscle strength, aerobic endurance, flexibility, agility, and dynamic balance. Higher scores in the SFT indicate better physical fitness.

    Measured: Baseline, 12-month, 5-year

  6. Longitudinal changes in physical fitness - Grip Strength Test

    Physical Fitness will be assessed with the Grip Strength Test. For this test, the best result from 3 trials for each hand will be recorded and summed.

    Measured: Baseline, 12-month, 5-year

  7. Longitudinal Changes in Plasma Alzheimer's Disease Biomarkers and Neuroimaging Measures

    Change and trajectory in plasma AD biomarkers and neuroimaging measures of brain structure and function. Specifically, plasma AD biomarkers include the concentration levels of phosphorylated tau (p-tau217 and p-tau181), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), all expressed in pg/mL, as well as the amyloid-β 42/40 ratio. Simultaneously, neuroimaging markers derived from structural MRI include hippocampal, lateral ventricular volumes, and White Matter Hyperintensities (WMH) - all normalized to total intracranial volume (TIV)-, and a composite measure of cortical thickness in "AD-signature" regions (PMID: 21490323).

    Measured: Baseline, 12-month, 5-year

  8. Economic Outcomes: Long-term Cost-Effectiveness and Cost-Utility

    Incremental cost-effectiveness ratios (ICERs) expressed as cost per unit improvement in global cognitive performance (PACC-exe), and the Incremental Cost-Utility Ratio (ICUR), expressed as the cost per Quality-Adjusted Life Year (QALY) gained based on EQ-5D-5L data.

    Measured: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07730671
Sponsor's protocol ID
PENSA+_BBRC2026
Acronym
PENSA+
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carlson MC, Parisi JM, Xia J, Xue QL, Rebok GW, Bandeen-Roche K, Fried LP. Lifestyle activities and memory: variety may be the spice of life. The women's health and aging study II. J Int Neuropsychol Soc. 2012 Mar;18(2):286-94. doi: 10.1017/S135561771100169X. Epub 2011 Dec 15.

    PubMed 22172155

  • Forcano L, Soldevila-Domenech N, Boronat A, Sanchez-Benavides G, Puig-Pijoan A, Lorenzo T, Aldea-Perona A, Suarez-Calvet M, Cuenca-Royo A, Gispert JD, Gomis-Gonzalez M, Minguillon C, Diaz-Pellicer P, Fauria K, Piera I, Langohr K, Dierssen M, Pizarro N, Mur-Gimeno E, Grau-Rivera O, Molinuevo JL, de la Torre R; PENSA working group. A multimodal lifestyle intervention complemented with epigallocatechin gallate to prevent cognitive decline in APOE- varepsilon4 carriers with Subjective Cognitive Decline: a randomized, double-blinded clinical trial (PENSA study). J Prev Alzheimers Dis. 2025 Sep;12(8):100271. doi: 10.1016/j.tjpad.2025.100271. Epub 2025 Jul 15.

    PubMed 40664536

  • Nishi SK, Babio N, Gomez-Martinez C, Martinez-Gonzalez MA, Ros E, Corella D, Castaner O, Martinez JA, Alonso-Gomez AM, Warnberg J, Vioque J, Romaguera D, Lopez-Miranda J, Estruch R, Tinahones FJ, Lapetra J, Serra-Majem JL, Bueno-Cavanillas A, Tur JA, Martin Sanchez V, Pinto X, Delgado-Rodriguez M, Matia-Martin P, Vidal J, Vazquez C, Daimiel L, Razquin C, Coltell O, Becerra-Tomas N, De La Torre Fornell R, Abete I, Sorto-Sanchez C, Baron-Lopez FJ, Signes-Pastor AJ, Konieczna J, Garcia-Rios A, Casas R, Gomez-Perez AM, Santos-Lozano JM, Garcia-Arellano A, Guillem-Saiz P, Ni J, Trinidad Soria-Florido M, Zulet MA, Vaquero-Luna J, Toledo E, Fito M, Salas-Salvado J. Mediterranean, DASH, and MIND Dietary Patterns and Cognitive Function: The 2-Year Longitudinal Changes in an Older Spanish Cohort. Front Aging Neurosci. 2021 Dec 13;13:782067. doi: 10.3389/fnagi.2021.782067. eCollection 2021.

    PubMed 34966270

  • Dickerson BC, Stoub TR, Shah RC, Sperling RA, Killiany RJ, Albert MS, Hyman BT, Blacker D, Detoledo-Morrell L. Alzheimer-signature MRI biomarker predicts AD dementia in cognitively normal adults. Neurology. 2011 Apr 19;76(16):1395-402. doi: 10.1212/WNL.0b013e3182166e96. Epub 2011 Apr 13.

    PubMed 21490323

  • Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

    PubMed 15085902

  • Ruiz Comellas A, Pera G, Baena Diez JM, Mundet Tuduri X, Alzamora Sas T, Elosua R, Toran Monserrat P, Heras A, Fores Raurell R, Fuste Gamisans M, Fabrega Camprubi M. [Validation of a Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)]. Rev Esp Salud Publica. 2012 Oct;86(5):495-508. doi: 10.4321/S1135-57272012000500004. Spanish.

    PubMed 23223762

  • Matton A, Stephen R, Daniilidou M, Barbera M, Alanko V, Ballin M, Ford J, Hemio K, Lehtisalo J, Rocha SL, Mangialasche F, Ngandu T, Rosenberg A, Saadmaan G, Udeh-Momoh C, Uusimaki K, Solomon A, Kivipelto M. Mechanisms of interventions targeting modifiable factors for dementia risk reduction. Mol Neurodegener. 2025 Jun 23;20(1):75. doi: 10.1186/s13024-025-00845-w.

    PubMed 40551205

  • Xicota L, Rodriguez-Morato J, Dierssen M, de la Torre R. Potential Role of (-)-Epigallocatechin-3-Gallate (EGCG) in the Secondary Prevention of Alzheimer Disease. Curr Drug Targets. 2017;18(2):174-195. doi: 10.2174/1389450116666150825113655.

    PubMed 26302801

  • Barbera M, Perera D, Matton A, Mangialasche F, Rosenberg A, Middleton L, Ngandu T, Solomon A, Kivipelto M. Multimodal Precision Prevention - A New Direction in Alzheimer's Disease. J Prev Alzheimers Dis. 2023;10(4):718-728. doi: 10.14283/jpad.2023.114.

    PubMed 37874092

  • Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.

    PubMed 39096926

  • Frisoni GB, Altomare D, Ribaldi F, Villain N, Brayne C, Mukadam N, Abramowicz M, Barkhof F, Berthier M, Bieler-Aeschlimann M, Blennow K, Brioschi Guevara A, Carrera E, Chetelat G, Csajka C, Demonet JF, Dodich A, Garibotto V, Georges J, Hurst S, Jessen F, Kivipelto M, Llewellyn DJ, McWhirter L, Milne R, Minguillon C, Miniussi C, Molinuevo JL, Nilsson PM, Noyce A, Ranson JM, Grau-Rivera O, Schott JM, Solomon A, Stephen R, van der Flier W, van Duijn C, Vellas B, Visser LNC, Cummings JL, Scheltens P, Ritchie C, Dubois B. Dementia prevention in memory clinics: recommendations from the European task force for brain health services. Lancet Reg Health Eur. 2023 Jan 31;26:100576. doi: 10.1016/j.lanepe.2022.100576. eCollection 2023 Mar.

    PubMed 36895446

  • Sindi S, Nasholm MS, Barbera M, Thunborg C, Li Y, Jonsson L, Mangialasche F, Qiu C, Kivipelto M. From dementia prevention research to global FINGER-based multi-domain interventions and implementation strategies. Cereb Circ Cogn Behav. 2025 May 30;9:100385. doi: 10.1016/j.cccb.2025.100385. eCollection 2025.

    PubMed 41017958

  • Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

    PubMed 25771249

  • Ngandu T, Solomon A, Lehtisalo J, et al. Long-term adherence to lifestyle changes and association with cognitive change: 11-year results from the FINGER randomized, controlled trial. Alzheimers Dement. 2025;21(Suppl 6):e106542. Published 2025 Dec 23. doi:10.1002/alz70860_106542.

  • Forcano L, Fauria K, Soldevila-Domenech N, Minguillon C, Lorenzo T, Cuenca-Royo A, Menezes-Cabral S, Pizarro N, Boronat A, Molinuevo JL, de la Torre R; PENSA Study Groupǂ. Prevention of cognitive decline in subjective cognitive decline APOE epsilon4 carriers after EGCG and a multimodal intervention (PENSA): Study design. Alzheimers Dement (N Y). 2021 Mar 31;7(1):e12155. doi: 10.1002/trc2.12155. eCollection 2021.

    PubMed 33816762

Questions about this trial

What is this clinical trial studying?

An observational study of Subjective Cognitive Decline (SCD), run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natàlia Soldevila Domènech, MPH, PhD ((+34) 93 316 09 90, nsoldevila@barcelonabeta.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Cognitive Performance (PACC-exe Composite Score) (time frame: Baseline, 12 months, and approximately 5 years after completion of the original PENSA intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07730671, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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